Kornimate/medical-research-clean huggingface dataset:
covid-19 advanced respiratory physiology (carp) study

Conditions: Respiratory Failure; Covid19; Biosensor

Summary: the anticipated second wave of covid-19 cases will present healthcare system challenges, including requirement to monitor large numbers of patients for deteriorating respiratory failure. rising respiratory rate can identify deterioration requiring escalation of care. however constant monitoring of respiratory rate can be challenging outwith critical care units due to feasibility and inaccuracy of intermittent measurements. wearable biosensors which allows for remote patient monitoring of rr is therefore attractive, particularly when combined in a dashboard with clinical summary data. this would establish source data and infrastructure for the training and validation of machine-learning models, with decision support risk-predictions prioritising alerts and clinician reviews.

altair medical has developed a pre-commercial investigational wearable (chest-worn) biosensor which can measure continuous respiratory rate and respiratory events. this sensor has been verified to have good correlation with reference impedance plethysmography data. inclusion criteria: all inpatients in the qeuh with respiratory failure from any cause. exclusion criteria: lack of capacity to consent physiology data will be correlated with event time-course data including oxygen and breathing support requirements, deterioration, hospital discharge and status at 28 days and 90 days post discharge. a small subset of patients will have further investigations - parasternal emg; thoracic electrical impedance tomography; forced oscillometry and post discharge altair and fitbit data. study analysis will include machine learning model development with the objective of developing risk-predictions for clinically significant deteriorations.

Eligibility criteria:
inclusion criteria: * inclusion criteria * adult patients with respiratory failure of any cause requiring hospital admission, oxygen therapy and routine news-2 physiology observations. * carp detailed sub-study adult patients with respiratory failure who are suitable for opportunistically acquired serial detailed physiology measurements taken alongside routine clinical care by study team. * carp follow-up remote-monitoring sub-study adult patients with respiratory failure who have provided informed consent and have a smartphone to connect to fitbit and lenus accounts for postdischarge wearable device data capture. exclusion criteria: * exclusion criteria • lack of capacity or inability to comprehend informed consent.
study of environmental enteropathy and malnutrition in pakistan

Conditions: Malnutrition, Child; Enteropathy; Vaccine Response Impaired; Stunting; Gastrointestinal Disease

Summary: environmental enteropathy (ee) is an acquired sub-clinical inflammatory gut condition in which alterations in intestinal structure, function, and local and systemic immune activation lead to impaired vaccine responses, decreased cognitive potential and undernutrition in low-middle income countries. approximately half of all global deaths in children aged less than five years are attributable to undernutrition making the study of ee an area of critical priority. however, given the operational limitations and ethical considerations for safely obtaining intestinal biopsies from young children in low resource settings, there have been few detailed investigations of human intestinal tissue in this vulnerable patient group for whom reversal of ee would provide the greatest benefit. ee biomarkers have been studied in different settings but these have not been correlated with the gold standard histopathology confirmation. the study of environment enteropathy and malnutrition in pakistan (seem pakistan) is designed to better understand the pathophysiology, predictors, biomarkers, and potential management strategies of ee to inform strategies to eradicate this debilitating pathology.


Eligibility criteria:
inclusion criteria: * children aged 0-6 months from matiari, pakistan with weight for height z score (whz) \< -2 at the time of enrollment * children aged 0 to 6 months from matiari, pakistan who would be growing normally, with whz \> 0, to serve as controls * healthy control children under the age of 3 years, who will undergo endoscopy at cchmc * children under the age of 6 years with newly diagnosed celiac disease per endoscopy at cchmc * children under the age of 10 years with newly diagnosed crohn's disease per endoscopy at cchmc exclusion criteria: * for healthy control children \< 3 years old undergoing endoscopy at cchmc, biopsies and diagnoses should not supportive of eosinophilic esophagitis * for healthy control children \< 3 years old undergoing endoscopy at cchmc, biopsies and diagnoses should not supportive of celiac disease * for healthy control children \< 3 years old undergoing endoscopy at cchmc, biopsies and diagnoses should not supportive of inflammatory bowel disease * for healthy control children \< 3 years old undergoing endoscopy at cchmc, children should not have been treated with antibiotics ≤ 4 weeks prior to endoscopy
empagliflozin and atrial fibrillation treatment

Conditions: Atrial Fibrillation; Heart Failure; Obesity; Diabetes Mellitus

Summary: the primary purpose of this trial is to evaluate the impact of empagliflozin, as compared with placebo, in patients with diabetes mellitus or overweight, heart failure and atrial fibrillation.

a 24-month randomized, single-blind, placebo-controlled trial to investigate the efficacy of empagliflozin to reduce atrial fibrillation burden in patients with diabetes mellitus or overweight, heart failure and atrial fibrillation in which a rhythm control strategy is indicated.

Eligibility criteria:
inclusion criteria: 1. age 18-80 years 2. diabetes mellitus or body mass index over 25 kg/m2 3. heart failure 4. new york heart association (nyha) functional classification: ii or iii 5. documented atrial fibrillation 6. understands the nature of the study, treatment procedure and provides written informed consent 7. willing to comply with specified pre-, post- and follow-up testing, evaluations and requirements 8. expected to remain available for at least 24 months after enrollment exclusion criteria: 1. permanent atrial fibrillation 2. current use or prior use of a sodium-glucose co-transporter (sglt) 2 inhibitor or combined inhibitor of sglt-1 and sglt-2 (all the other antidiabetic drugs are permitted performing an accurate glycemic control) 3. known allergy or hypersensitivity to any sglt-2 inhibitors 4. history of ketoacidosis 5. need or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial 6. new york heart association (nyha) functional classification: i or iv 7. unstable angina 8. presence of any disease that is likely to shorten life expectancy to \< 1 year 9. any cardiac surgery within three months prior to enrolment 10. awaiting cardiac transplantation or other cardiac surgery within the next year 11. myocardial infarction within 60 days prior to enrolment 12. contraindications to oral anticoagulation 13. active systemic infection or sepsis 14. left atrial thrombus (e.g., transesophageal echocardiography, computed tomography and intracardiac echocardiography) 15. history of a documented thromboembolic event such as stroke or transient ischemic neurological attack in the three months prior to enrollment 16. currently enrolled in another trial that has not completed the required follow-up period and would conflict with this study 17. chronic liver diseases 18. chronic kidney disease (creatinine clearance \< 45 ml/min) 19. pregnant or breast-feeding mothers 20. any other clinical condition that might jeopardize patient safety during participation in this trial or prevent the subject from adhering to the trial protocol
tension-free vaginal tape obturator for the treatment of urinary incontinence -long-term follow-up

Conditions: Urinary Incontinence,Stress; Urinary Incontinence, Urge

Summary: the efficacy of tvt-o (tension-free vaginal tape obturator) is well established in patients with stress urinary incontinence (sui). the objective of this study was to evaluate the efficacy, safety and patient satisfaction of tvt-o in patients suffering from primary, mixed (mui) or recurrent urinary incontinence (ui) in long-term follow-up.

the long-term results after tvt-o have been scarce. at five years no significant differences were seen between tvt (tension-free vaginal tape) and tvt-o for female sui in a randomized trial. in two studies the patients were followed-up for ten years after the tvt-o procedure. the first randomized study reporting long term outcomes of tvt-o and outside-in tot (transobturator tape) in women with urodynamic mixed urinary incontinence (mui) showed that transobturator tension-free vaginal tapes are associated with a good and sustained patient-reported success rate. the success of the incontinence procedures should be assessed not only with objective measures but also with methods evaluating subjective satisfaction. the aim of this study was to evaluate the efficacy, safety and overall patient satisfaction of the tvt-o technique in a long-term follow-up of patients suffering from primary or recurrent sui or mui.

Eligibility criteria:
inclusion criteria: we included all the patients who underwent the tvt-o operation between august 2004 and october 2011 in our hospital, turku university hospital finland. exclusion criteria: no exclusion criteria were applied.

Keywords: tvt-o long-term follow-up retrospective
observation of outcomes and side effects of cesium-131 in combination with external beam radiation for the treatment of intermediate to high risk prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to observe psa response and incidence of side effects in patients diagnosed with intermediate to high risk prostate cancer and treated with cesium-131 in combination of external beam therapy.


Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma of the prostate * clinical stage t1c - t2c (ajcc 6th edition), nx/n0, m0 * karnofsky performance score of 90 to 100 * greater than or equal to 18 years of age * prostate volumes by trus ≤ 60 cc * i-pss score \< 15 (alpha blockers allowed) * signed study-specific informed consent form prior to study entry intermediate risk prostate cancer as determined by the following: * gleason sum of 7; psa less than 10.1 ng/ml; stage t2a or less * gleason sum 6 or less; psa \>10.0 and \< 20.1ng/ml; stage t2a or less * gleason sum 6 or less; psa \< 10.1; stage t2b high risk prostate cancer as determined by the following: * any gleason sum; psa greater than 20 ng/ml; stage t2c or less * gleason sum \> 7; any psa; stage t2c or less * any gleason sum; any psa; stage t2c * any two or three intermediate risk factor exclusion criteria: * lymph node involvement (n1) * evidence of distant metastases (m1) * any hormonal blockade or therapy that: * has persisted for more than 6 months by time of protocol screening; or * is ongoing within 3 months of study enrollment * radical surgery for carcinoma of the prostate * prior pelvic radiation * previous or concurrent cancers other than basal, in situ, or squamous cell skin cancers unless disease-free for ≥ 5 years * major medical or psychiatric illness, which in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up * hip prosthesis * inability or refusal to provide informed consent

Keywords: prostate cancer intermediate risk high risk brachytherapy cesium-131 seed brachytherapy intermediate and high risk cancer of the prostate
digital ocular fundus photography in the emergency department: a new application for telemedicine?

Conditions: Headache; Acute, Focal Neurologic Disease; Severely Elevated Blood Pressure; Acute Visual Loss

Summary: the purpose of this study is to determine if non-dilated retinal photography in the emergency room improves the diagnosis of papilledema (optic nerve swelling) in patients with neurologic disease compared to direct ophthalmoscopy.


Eligibility criteria:
inclusion criteria: * presenting complaint of headache, acute focal neurologic disease, or acute visual changes * diastolic blood pressure \>= 120 * age 18 or older exclusion criteria: * unable to sit-up, not interested in participation, confused * age 17 or younger
evaluation of hemo2life® for kidney graft preservation (oxyop): 4 years follow-up

Conditions: Transplant; Complication, Failure

Summary: 4 years follow-up of the oxyop study.

oxyop (nct02652520 phrc) was a safety study evaluating the use of an oxygen carrier hemo2life® as an additive in organ preservation solution in 60 transplanted kidneys. this was a national multicenter (6 centers) open-labeled safety study on hemo2life® that included 58 recipients. the first patient was included on march 24th, 2016 and the study was completed on february 23th, 2018 (1 year of recruitment and 1 year of follow-up). we also analyzed some efficacy secondary end points using a paired analysis (local kidney receiving hemo2life® versus contralateral kidney transplanted elsewhere in france). oxyop4 aims to analyse 4 years results.

Eligibility criteria:
inclusion criteria: * informed patients participating to the oxyop study exclusion criteria: * patients refusing to participate

Keywords: renal transplantation organ preservation oxygen carrier
resilient - an online multidimensional treatment to promote resilience after a disaster: randomized controlled trial protocol

Conditions: Post Traumatic Stress Disorder; Insomnia; Depression

Summary: background. the wildfires on may 1, 2016 in fort mcmurray, alberta (canada), destroyed approximately 2,400 homes and buildings and led to massive displacement of approximately 88,000 people. many individuals faced direct or potential threat to their life or health, or significant losses, and many months later, families were still living through ongoing adversity and uncertainty as they adapted to new or temporary homes, schools and workplaces. alberta health services estimated in august 2016 that mental health staff in the city had received 20,000 referrals since may, compared to 1,200 referrals each year. objectives. the overarching aim of this project is to understand the needs of the fort mcmurray population in terms of mental health and to widely disseminate evidence-based tools to promote resilience. more specifically, we will assess the efficacy of an online self-help intervention targeting post-traumatic resilience on specific symptoms (post-traumatic stress disorder \[ptsd\], insomnia, depression). method. 1,510 phone surveys have been conducted in may-july 2017 to assess the prevalence of ptsd, insomnia and depression in the evacuees from the fort mcmurray wildfires (t0). after the survey, 697 participants expressed interest to participate in the longitudinal arm of the study, which will include four in-depth assessments with online questionnaires (t1 to t4) and a diagnostic interview (t1 only). a period of six months will separate all four times of assessment. participants with post-traumatic stress symptoms (expected n = 150) will be randomised either to the treatment condition (n = 75) or to a waitlist control condition (n = 75) after completion of t2. data analyses. primary outcomes will be post-traumatic, depressive and insomnia symptom severity, measured with validated self-report questionnaires. secondary outcomes will include cognitive, behavioural and social indicators, as well as general mental health and post-traumatic growth. several probable moderators of treatment will be examined, including sociodemographic characteristics, level of exposure, and continuing stressors. foreseen impacts. if found effective in reducing symptoms, the results of this study have the potential to impact positively the fort mcmurray community. indeed, a direct and concrete deliverable of this research project will be to provide an extended (at least two years) and free access to the online intervention specifically tailored to this population's needs.


Eligibility criteria:
inclusion criteria: * significant post-traumatic stress symptoms (pcl-5 ≥ 23) or * some post-traumatic stress symptoms (pcl-5 ≥ 10) with at least mild depressive symptoms (phq-9 ≥ 5) and/or subclinical insomnia symptoms (isi ≥ 8).

Keywords: mental health post-traumatic stress disorder psychological distress sleep
preoperative assessment of aortic valve stenosis and coronary artery disease

Conditions: Aortic Valve Stenosis; Coronary Disease

Summary: we sought to determine whether the dual-source computed tomography assessment of aortic valve stenosis and coronary artery disease is equivalent to or even better than conventional invasive coronary angiography and transthoracic echocardiography.

until now invasive coronary angiography has established itself for the assessment of symptomatic aortic valve stenosis. literature shows a good correlation between msct, mri, tte and tee for evaluating the severity of the aortic valve stenosis. the dual-source computed tomography (dsct) is capable of assessing coronary arteries with a high sensitivity and specificity in term of relevant stenosis (\>50%), due to its excellent spatial and temporal resolution. this study includes the assessment of patients with symptomatic valve stenosis. the severity of the aortic valve stenosis is being assessed by dsct and tte. significant coronary artery stenosis and its localisation are assessed by dsct and invasive coronary angiography. we examine the correlation between dsct on one side and either tte or invasive coronary angiography on the other.

Eligibility criteria:
inclusion criteria: * patients with aortic valve disease who were scheduled to undergo cardiac surgery exclusion criteria: * hemodynamic instability * renal insufficiency (serum creatinine level \> 133umol/l) * known allergy to iodinated contrast agents * non-treated hyperthyreosis

Keywords: dsct, coronary artery disease, aortic valve stenosis
effectiveness and cost effectiveness of peer mentors in reducing hospital use

Conditions: Serious Mental Illness

Summary: the current study, through a randomized controlled design, will evaluate the effectiveness of peer support, as compared to usual care and to an equivalent amount of support offered by peer case managers and non-peer recovery mentors, in reducing hospital days and readmissions and in promoting recovery and community inclusion among adults with mental illnesses with histories of multiple hospitalizations. the current study evaluates the cost-effectiveness of adding peer support to the array of services available to persons with serious mental illnesses who have histories of multiple hospitalizations and will test a theoretical model of the active ingredients of peer support, focusing specifically on the roles of 1) instillation of hope through positive self-disclosure; 2) role modeling of self-care and exploring new ways of using experiential knowledge; and 3) a trusting relationship characterized by acceptance, understanding, and empathy with conditional regard.


Eligibility criteria:
inclusion criteria: * 2 or more psychiatric hospitalizations in the past year * a diagnosis of serious mental illness exclusion criteria: * dementia or other organic condition limiting ability to provide informed consent

Keywords: peer support cost effectiveness reducing hospital use serious mental illness
evaluating the use of sublingual sufentanil in patients with suboxone treatment

Conditions: Acute Pain

Summary: in this case series study, the investigators are testing the hypothesis that sublingual sufentanil (dsuvia) will improve postoperative pain management in the post anesthesia care unit (pacu) in ambulatory surgery patients taking suboxone.


Eligibility criteria:
inclusion criteria: * age range 18-100 years * currently taking suboxone * asa (american society of anesthesiology) physical score 1-3 * able to provide a signed informed consent * general anesthesia (either endotracheal intubation or laryngeal mask airway) or mac (monitored anesthesia care) without the use of regional anesthesia exclusion criteria: * known allergic reactions to dsuvia and its excipients * severe respiratory illness including exacerbation of asthma attack * significant intraoperative hemodynamic instability * use of regional anesthesia techniques
psychological evaluation according colonic colonization by escherichia coli of patients after colorectal surgery

Conditions: Colorectal Cancer

Summary: the purpose of this study is to determine whether the presence of pathogenic escherichia coli in colon is associated with psychiatric disorders.

colonic colonization by pathogenic escherichia coli was determined when patients were operated on for colorectal cancer. several years later, the investigator investigate past and actual psychiatric disorder using the mini international neuropsychiatric interview (mini). actual depression and anxiety scores are evaluated with hamilton scales and personality traits are investigated using personality inventory for dsm-5 (pid-5). anxiety and depression scores, psychiatric diagnoses (mini) and personality traits were compared in patients according to escherichia coli presence/absence.

Eligibility criteria:
inclusion criteria: * patients operated on for colorectal cancer in the digestive surgery department of clermont-ferrand hospital * patients older than 18 years, * patients whose escherichia coli colonization was analyzed after surgery * patients which are always followed by the digestive surgery department. exclusion criteria: * patients with dementia will not be included, according to the mmse score: * 22 if no grade * 23 if study certificate or cap or college without patent * 25 if patent or school without the tray * 26 or more when bin

Keywords: escherichia coli microbiota colorectal cancer psychiatric disorders personality traits
carious tissue selective removal on permanent posterior teeth.

Conditions: Dental Caries; Dental Materials

Summary: this study is a prospective randomized controlled study of patients who come to the university. the aim is to evaluate the success rate of selective removal of carious tissue in deep lesions of posterior teeth. three different materials will be used as liners (vitrebond ™plus, biodentine™, and theracal™ lc). post-operative pain, clinical, and radiographic success will be evaluated at one, two, and five-year follow-up. the null hypothesis is that there will be no statistically significant differences in rates of successful treatment with the three materials used.


Eligibility criteria:
inclusion criteria: * patients that demonstrate understanding of the study and willingness to participate as evidenced by signing the voluntary informed consent and received a signed and dated copy of the informed consent form. * understands and is willing to comply with all study procedures and restrictions. * not presence of clinically significant and relevant abnormalities of clinical history or oral examination. * diagnosis of normal pulp or reversible pulpitis. * no presence of periapical periodontitis * posterior teeth exclusion criteria: general: patients with systemic diseases, diabetes, immunocompromised and pregnant women, or any clinically significant or relevant oral abnormalities. specific: impossibility of restoration, diagnosis of irreversible pulpitis or necrosis, preoperative pain

Keywords: dental caries dental materials outcome postoperative pain